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Ischemic StrokePhase 3STABLEDNCT03777631

STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study

A Phase 3 study testing Catheter ablation in people with Ischemic Stroke and Atrial Fibrillation Non-Rheumatic, run by Nippon Medical School at 46 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies, but risk and benefit of CA has not been well elucidated in NVAF with recent cerebral infarction in prospective randomized trials. Read more about this study

Who is it for?
Ages 20 to 85 years
What is being tested?
Catheter ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
46 sitesJapan
Study dates
1 Apr 2018to 31 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥20 or ≤85 years at time of giving informed consent
  • Nonvalvular atrial fibrillation
  • History of stroke in previous 6 months
  • Current or planned treatment with edoxaban
  • Modified Rankin scale ≤3

Who cannot join

  • Symptomatic paroxysmal AF resistant to anti-arrhythmic drugs
  • Presence of left atrial thrombus and left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
  • Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy.
  • Presence of severe renal disorder (estimated creatinine clearance <30 mL/min by Cockroft-Gault equation)
  • Previous CA or surgical intervention for AF
  • History of treatment with a left atrial appendage closure device
Show all 14Show fewer
  • Left atrial diameter ≥55 mm on transthoracic echocardiography
  • Ejection fraction ≤35% on transthoracic echocardiography
  • Persistent AF for ≥10 years
  • Pregnant or possibility of pregnancy
  • Unlikely to complete the study, such as due to progressive malignant tumor
  • Participating or planning to participate in another clinical trial
  • Unwilling to participates
  • Judged as incompatible for the study by the investigators

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Japan46 sites

  • Ichinomiyanishi Hospital

    Aichi

  • Hirosaki Stroke and Rehabilitation Center

    Aomori

  • Hirosaki University Hospital

    Aomori

  • Kimitsu Chuo Hospital

    Chiba

  • New Tokyo Heart Clinic

    Chiba

  • New Tokyo Hospital

    Chiba

  • Nippon Medical School Chiba Hokusoh Hospital

    Chiba

  • Kokura Memorial Hospital

    Fukuoka

  • National Hospital Organization Kyushu Medical Center

    Fukuoka

  • Ogaki Municipal Hospital

    Gifu

  • Brain Attack Center Ota Memorial Hospital

    Hiroshima

  • Fukuyama Cardiovascular Hospital

    Hiroshima

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima

  • Hiroshima University Hospital

    Hiroshima

  • Suiseikai Kajikawa Hospital

    Hiroshima

  • Teine Keijinkai Hospital

    Hokkaido

  • Hyogo Brain and Heart Center

    Hyōgo

  • Hyogo College of Medicine College Hospital

    Hyōgo

  • Kitaharima medical center

    Hyōgo

  • Odawara Cardiovascular Hospital

    Kanagawa

  • Seisho Hospital

    Kanagawa

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa

  • Kumamoto Red Cross Hospital

    Kumamoto

  • Saiseikai Kumamoto Hospital

    Kumamoto

  • Iwate Medical University

    Morioka

  • Iwate Prefectural Central Hospital

    Morioka

  • Nagasaki University Hospital

    Nagasaki

  • Tenri Hospital

    Nara

  • Okayama Red Cross Hospital

    Okayama

  • National Cerebral and Cardiovascular Center

    Osaka

  • National Hospital Organization Osaka National Hospital

    Osaka

  • Osaka General Medical Center

    Osaka

  • Saga Medical Center Koseikan

    Saga

  • Saitama Medical Center

    Saitama

  • Saitama Medical University International Medical Center

    Saitama

  • Dokkyo Medical University Hospital

    Tochigi

  • Jichi Medical University Hospital

    Tochigi

  • Jikei University Hospital

    Tokyo

  • Juntendo University Hospital

    Tokyo

  • Kyorin University Hospital

    Tokyo

  • Nippon Medical School

    Tokyo

  • NTT Medical Center Tokyo

    Tokyo

  • Showa University Koto Toyosu Hospital

    Tokyo

  • Tokyo Women's Medical University Hospital

    Tokyo

  • Tsuruoka Kyoritsu Hospital

    Yamagata

  • Tsuruoka Municipal Shonai Hospital

    Yamagata

Other trials in Japan

About this study

Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies, but risk and benefit of CA has not been well elucidated in NVAF with recent cerebral infarction in prospective randomized trials.

Read the detailed description

In patients with NVAF, stroke is an independent risk factor for a subsequent cerebral infarction. Although anticoagulant therapy can effectively reduce thromboembolic events, the reported annual recurrence rate in NVAF and previous stroke patients in the "real-world" is not low even with appropriate antithrombotic treatment; 8.6% in patients with "guideline adherent" antithrombotic therapy and around 5% in patients treated with anticoagulant therapy. NVAF and recent stroke is high-risk population for stroke recurrence even with anticoagulant therapy, and developing optimal secondary prevention strategy is an urgent task.

Catheter ablation (CA) is now widely used to treat symptoms related to NVAF. Some retrospective studies showed a beneficial effect of CA for stroke prevention using age-/sex-matching or propensity-score matching. Moreover, CA have a potential to improve survival or prevent heart failure development in patients with AF. However, the effect of CA for secondary stroke prevention or impact of CA for NVAF patients with recent ischemic stroke for survival or developing heart failure has not been evaluated in a prospective randomized trial. Therefore, in the present study, we intend to compare two groups of patients with NVAF with a history of cerebral infarction: a group receiving standard medical therapy (control group) and a group receiving standard medical therapy plus CA (CA group).

Being tested
Catheter ablation
Keywords
anticoagulation treatment, catheter ablation
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter ablationProcedure or surgery

    CA should be performed within 1-6 months from the onset of cerebral infarction. CA is based on pulmonary vein isolation, with atrial ablation as required.

Study groups in NCT03777631
Study groupRoleWhat they receive
Standard medical therapy groupNo interventionThe preferred anticoagulant is edoxaban. Antiarrhythmic drugs are administered as needed for the patient by well-trained cardiologists.
Catheter ablation groupActive comparatorCatheter ablation (CA) should be performed within 1-6 months from the onset of cerebral infarction. CA is based on pulmonary vein isolation, with atrial ablation as required. For conducting CA by a trained and experienced cardiologist, only institutions in which performed >100 CA annually were participated in the present study in principle.
Receives: Procedure: Catheter ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.

    Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.

    Measured: Up to 6 years

Secondary outcomes (10)

  1. Recurrence of cerebral infarction

    Recurrence of cerebral infarction

    Measured: Up to 6 years

  2. Systemic embolism

    Symptomatic systemic embolism to other regions than brain, e.g. peripheral or visceral arteries

    Measured: Up to 6 years

  3. All-cause death

    All-cause death

    Measured: Up to 6 years

  4. Cardiovascular death

    Cardiovascular death

    Measured: Up to 6 years

  5. Hospitalization for heart failure

    Hospitalization for heart failure

    Measured: Up to 6 years

  6. Any bleeding

    Any bleeding

    Measured: Up to 6 years

  7. Intracranial hemorrhage

    Intracranial hemorrhage

    Measured: Up to 6 years

  8. Composite events

    all-cause death, onset of stroke, systemic embolism, hospitalization for heart failure, and serious adverse event caused by CA

    Measured: Up to 6 years

  9. The rate of and related factors to discontinuation of Edoxaban

    The rate of and related factors to discontinuation of Edoxaban

    Measured: Up to 6 years

  10. Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban

    Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2018
  2. Study start1 Apr 2018
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The included patients were randomly allocated to two groups: (1) Standard medical treatment group and (2) Catheter ablation additional group.
Masking
None (open label)
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777631
Sponsor's protocol ID
LIX-DS-16018
Acronym
STABLED
Status last verified
Nov 2023
First submitted
3 Nov 2018
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kimura K, Nishiyama Y, Iwasaki YK, Shimizu W, Toyoda K, Sakamoto Y, Katano T, Yamamoto T, Takeuchi M, Kumagai K, Tsuto K, Sugi K, Kusano K, Koga M, Okubo S, Sato T, Hamaguchi H, Yoshida A, Kuriki A, Tanno K, Kitagawa K, Hagiwara N, Daida H, Iguchi Y, Fujimoto S, Miyamoto S, Fukuzawa M, Sugimoto M, Takita A, Otsuka T, Okumura K. Catheter Ablation and Oral Anticoagulation for Secondary Stroke Prevention in Atrial Fibrillation: The STABLED Randomized Clinical Trial. JAMA Neurol. 2026 Apr 1;83(4):329-338. doi: 10.1001/jamaneurol.2026.0155.

    PubMed 41770549

  • Sakamoto Y, Nishiyama Y, Iwasaki YK, Daida H, Toyoda K, Kitagawa K, Okumura K, Kusano K, Hagiwara N, Fujimoto S, Miyamoto S, Otsuka T, Iguchi Y, Kanamaru T, Yamamoto T, Kaburagi J, Kimura T, Matsumoto T, Kimura K, Shimizu W; STABLED Study Investigators. Design and rationale of the STroke secondary prevention with catheter ABLation and EDoxaban clinical trial in patients with non-valvular atrial fibrillation: The STABLED study. J Cardiol. 2019 Dec;74(6):539-542. doi: 10.1016/j.jjcc.2019.06.002. Epub 2019 Jul 20.

    PubMed 31337525

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Catheter ablation in people with Ischemic Stroke and Atrial Fibrillation Non-Rheumatic, run by Nippon Medical School at 46 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure. (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03777631, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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